Strategies to Improve Appropriate Referral to Rheumatologists

• ClinicalTrials.gov Identifier: NCT03454438
• Recruitment Status: Active, not recruiting
• First Posted: March 5, 2018
• Last Update Posted: February 24, 2021
• Sponsor: Maasstad Hospital
• Information provided by (Responsible Party): Maasstad Hospital

Study Description

Brief Summary:

The aim of this cluster randomized controlled trial is to improve the number of effectively referred patients with IRD to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of IRD by specialists in a primary care setting compared to usual care. In addition, the investigators want to provide tools for the general practitioner to recognise IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.

Condition or disease	Intervention/treatment	Phase
Rheumatic Disease; Arthralgia	Procedure: Referral strategies	Not Applicable

Detailed Description:

Rationale: Currently, only 22% of all patients referred to the rheumatologist by primary care are diagnosed with an inflammatory rheumatic disease (IRD). Previous research has shown that structured referral sheets and community-based specialist service improve appropriateness of referrals.

Objective: The aim of this study is to improve the number of effectively referred patients with IRD to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of IRD by specialists in a primary care setting compared to usual care. In addition, the investigators want to provide tools for the general practitioner to recognise IRD and improve early referral of patients with IRD, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.

Study design: Cluster randomized trial with randomization of general practitioner clinics.

Study population: Primary care patients of 18 years or older who are suspected of an IRD and considered by a GP for referral to a rheumatologist.

Intervention: One group of GPs will use a standardized referral strategy for IRD, another group will consist of triage by a rheumatologist in the local primary care clinic, the third group is usual care.

Main study parameters/endpoints: Percentage of patients diagnosed with an IRD by a rheumatologists after 12 months. In addition, cost effectiveness, quality of life, work participation and health care costs at baseline and after 12 months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no additional risk to participating patients. Patients might benefit from early referral since the referral pro formas point out important aspects of IRD that are frequently overlooked. Patients will be requested to fill in three online questionnaires related to quality of life, work participation and socio-economic costs. There are no additional visits, physical examinations or other tests.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 888 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Strategies to Improve Appropriate Referral to Rheumatologists
• Actual Study Start Date: February 28, 2017
• Actual Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: August 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Algorithm; Use of electronic structured referral sheets using the algorithms for rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis.	Procedure: Referral strategies; Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
Experimental: Triage; Triage by rheumatologist in a primary care setting.	Procedure: Referral strategies; Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
No Intervention: Usual care; Control group consisting of usual care.

Outcome Measures

Primary Outcome Measures :

1. Percentage of appropriate referred patients [ Time Frame: 12 months ]
   Percentage of appropriate referred patients as proportion of all patients referred to the rheumatologist by the general practitioner (GP). Appropriate referred defined as patient diagnosed with an inflammatory rheumatic disease (IRD) as assessed by a rheumatologist, with an IRD as final diagnosis.

Secondary Outcome Measures :

1. EuroQoL Health questionnaire [ Time Frame: 12 months ]
   The standard analysis for health-related quality of life in cost-effectiveness research, tool in determining Quality adjusted life years (QALYs).
2. iMTA Medical Consumption Questionnaire [ Time Frame: 12 months ]
   Collects information on non-disease specific health-care consumption.
3. iMTA Productivity Cost Questionnaire [ Time Frame: 12 months ]
   Measurement of productivity loss and work participation.
4. Health-care costs [ Time Frame: 12 months ]
   Amount of outpatient clinic visits (visits to medical specialist, supporting staff, other staff), diagnostics (laboratory analyses, imaging), therapy (medication, medical procedures, over the counter medication), general practitioner consultation, medication use prescribed by general practitioner.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• A primary care patient who is referred by the GP to the rheumatology outpatient clinic
• Subject must be able to understand and communicate with the rheumatologist
• Participant must give a written signed and dated informed consent before enrolment.

Exclusion Criteria:

• Limited understanding of the Dutch language.
• Legally incapable or vulnerable subject as described in the Medical Research with Human Subjects Act (WMO).

Contacts and Locations

Locations

Netherlands

Maasstad Hospital

Rotterdam, Zuid Holland, Netherlands, 3079

Sponsors and Collaborators

Maasstad Hospital

Investigators

• Principal Investigator: Angelique Weel-Koenders; Maasstad Hospital

More Information

• Responsible Party: Maasstad Hospital
• ClinicalTrials.gov Identifier: NCT03454438
• Other Study ID Numbers: The JOINT referral study
• First Posted: March 5, 2018
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maasstad Hospital:

Referral; Primary care; Rheumatologist

Additional relevant MeSH terms:

Rheumatic Diseases; Arthralgia; Collagen Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Joint Diseases; Pain; Neurologic Manifestations